Challenge:
A biotech client had developed a generic version of a major anti-diabetic peptide drug, and wanted a clearer understanding of the product's registrability, as well as support with defining the various data packages that would be required in the submission.
Solution:
Alacrita's regulatory team addressed the following items:
- Defined the nonclinical data package needed for registration as a biosimilar/generic in both EU and US, with high level outline design for any additional recommended studies, and identification of those nonclinical studies (in vitro/in vivo) that can be performed with API vs. those to be performed with drug product;
- Defined the clinical package needed for registration as a biosimilar in both EU and US, with high level outline design for recommended studies;
- Identified the sections of the eCTD that needed to be populated for Modules 4 and 5, and where it is acceptable to have justifications for missing data (and what those justifications would be);
- Reviewed the qualitative and quantitative composition of the client's product vs. the reference medicinal product to determine whether an abbreviated data package can be proposed;
- Assessed acceptability of current manufacturing process flow.